K790610 is an FDA 510(k) clearance for the SIGMOIDOSCOPE TIPLESS. This device is classified as a Sigmoidoscope And Accessories, Flexible/rigid (Class II - Special Controls, product code FAM).
Submitted by Welch Allyn, Inc. (Walker, US). The FDA issued a Cleared decision on April 23, 1979, 25 days after receiving the submission on March 29, 1979.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Examine And Perform Procedures Within The Sigmoid (descending) Colon.
| 510(k) Number | K790610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 1979 |
| Decision Date | April 23, 1979 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FAM — Sigmoidoscope And Accessories, Flexible/rigid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine And Perform Procedures Within The Sigmoid (descending) Colon |